Ensuring Patient Safety and Continued Innovation Must Stand As Focus Of Follow-On Biologics Debate

Imperative To Recognize Differences Between Biologics and Other Drugs

Imperative To Recognize Differences
Between Biologics and Other Drugs


WASHINGTON, D.C. (September 29, 2006) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding legislation introduced by Senator Charles Schumer, Senator Hillary Rodham Clinton and U.S. Representative Henry Waxman regarding follow-on biologics:


“Biological products are fundamentally different from traditional drugs in their complexity, development and production processes.  As a result of these differences, significant scientific and safety issues must be addressed before moving to establish any legislative or regulatory pathway for the approval of follow-on biological products.


“BIO believes that any evaluation of whether or how to authorize such a pathway must fully address both how to ensure patient safety and how to maintain incentives that spur continued innovation, including strong protections for intellectual property rights and access to capital. 


 “It is critical in the first instance to recognize the substantive and important differences between biologics and traditional drugs.  Unlike most traditional drugs, biologics are complex substances produced using living organisms.  It is imperative that the U.S. Food and Drug Administration (FDA) continue to require a full complement of data, including clinical evidence, to demonstrate safety and effectiveness for all biotechnology products.  Patients should not have to accept greater risks or uncertainties in using a follow-on product than when they use an innovator's product.


“A number of complex issues regarding intellectual property (IP) and trade secrets also must be considered.  Any pathway to the development of a follow-on product must not reduce or infringe the IP rights of innovator companies.  A legal framework for such a pathway must recognize the importance of intellectual property rights as a catalyst for innovation and provide adequate protections to help ensure companies are able to compete for and secure the capital necessary for innovation.


“For more than 20 years, the exceptional creativity of the biotechnology industry has been directed toward discovering, developing, and delivering innovative treatments for patients worldwide, in many cases providing the first approved treatment for a condition.  BIO members invest heavily in research and development, and are committed to creating new therapies that will help patients live longer and better lives.  We want to ensure our continued ability to do so.  We hope to work with the full Congress, the FDA and all other key stakeholders should this debate move forward.”